Parascript® AccuDetect® ACCFFDM00170

GUDID M760ACCFFDM00170

Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device intended to aid radiologists reading mammograms. It is a proprietary software application designed to process FFDM images. The digital mammography images are automatically analyzed to identify areas suspicious for possible soft tissue densities and/or calcifications. Results are displayed on a computer monitor for review by a radiologist. The radiologist is instructed to first review each case in the conventional manner and then re-examine the case utilizing the information supplied by the Parascript® AccuDetect system before making a final assessment for the case. AccuDetect® is not a diagnostic device, as the CAD marks are intended to be used to assist only in detection and not in interpretation. Therefore, AccuDetect® can assist a radiologist in detecting areas of concern that would have been missed without its use, but if used properly it cannot cause a radiologist to miss areas of concern that would have been detected without AccuDetect®.

PARASCRIPT, LLC

Radiology DICOM image processing application software

• Primary Device ID: M760ACCFFDM00170
• NIH Device Record Key: f6801c2f-9428-4b65-aa1c-f1b2cb6c27b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parascript® AccuDetect®
• Version Model Number: 7.0
• Catalog Number: ACCFFDM00170
• Company DUNS: 957279706
• Company Name: PARASCRIPT, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M760ACCFFDM00170 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P120004

FDA Product Code

• MYN: Analyzer,Medical Image

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-02-29

On-Brand Devices [Parascript® AccuDetect®]

• M760ACCFFDM00161: Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device intended to aid ra
• M760ACCFFDM00170: Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device intended to aid ra